Duns Number:055870299
Device Description: Cottle Septum Elevator 23cm Double Ended Septal Elevator 4x4mm sharp rounded end & 3mm spa Cottle Septum Elevator 23cm Double Ended Septal Elevator 4x4mm sharp rounded end & 3mm spatula end
Catalog Number
-
Brand Name
ASSI
Version/Model Number
ASSI.AG34326
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KAD
Product Code Name
Elevator, Ent
Public Device Record Key
e59231d0-d6ca-4831-bb2c-901b3916f1fb
Public Version Date
June 25, 2020
Public Version Number
1
DI Record Publish Date
June 17, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 400 |